Dr. Isis has a post up responding to a Protocol Review question "Noncompliance in survival surgery technique" published in Lab Animal [2010; 39(8)] by Jerald Silverman, DVM. His column is supposed to be in the vein of practicum case studies that are a traditional part of the discussion of ethical issues. Given X scenario, how should person A act? What is the ethical course of action? Was there a violation? Should it be reported/evaluated/punished.

We see these sorts of examples all the time in the ethics training courses to which we subject our academic trainees, particularly graduate students and postdocs.

These exercises frequently annoy me and this IACUC / Animals-in-Research question is of the classic type.

The problem will become apparent as soon as you review the critical features of the protocol. First, the observation of a problem:

a report from a veterinary technician that animals on which Linda Girard, a postdoctoral fellow, had operated two days earlier had a high incidence of wound dehiscence and infection. Some had to be euthanized. Necropsies revealed that the surgical procedure had not been carried out well.

Okay, so far so good. The system works in that the representatives of the Attending Veterinarian are providing back checking and oversight of the health and welfare of research animals. Problems are reported.

Investigation revealed that, contrary to training, a scientist has "[taken] protocol ‘shortcuts’ because she was overwhelmed with lab work":

wiping instruments with alcohol rather than sterilizing them between procedures on different animals when multiple animals were operated on during the same surgical session.

disinfected but did not change her surgical gloves between procedures on different animals.

used a continuous suture pattern to close the abdominal wound when individual sutures were specified.

sutured the peritoneum, muscle and skin as a unit, rather than closing the skin incision independently from the other layers.

Now the apparent question posed for IACUC members to consider is whether these actions required suspension (the postdoc had admitted fault and submitted to additional oversight of future work) and/or a report to OLAW from the local IACUC. Be that as it may...

This scenario is RIDICULOUS!!!!!!!!!!!!!!

It makes it really hard to take this seriously when there are multiple violations in direct contravention of the training provided by the University. And the icing on the cake is the clear negative health outcome for the experimental subjects.

This is like one of those academic misconduct cases where they say "The PI violates the confidence of review, steals research ideas that are totally inconsistent with anything she'd been doing before, sat on the paper review unfairly, called the editor to badmouth the person who she was scooping and then faked up the data in support anyway. Oh, and did we mention she kicked her cat?".

This is the typical and useless fare at the ethical training course. Obvious, overwhelmingly clear cases in which the black hats and white hats are in full display and provide a perfect correlation with malfeasance.

The real world is messier and I think that if we are to make any advances in dealing with the real problems, the real cases of misconduct and the real cases of dodgy animal use in research, we need to cover more realistic scenarios.

In this case, for example, we might focus on a case in which everything was according to training except for a single shortcut. Perhaps the disinfecting of gloves but not the change. Or the use of disinfected nonsterile gloves instead of sterile gloves. Or maybe the choice of sterilization of surgical tools in between animals with alcohol instead of a hot bead unit or a more effective chemical sterilization bath.

One. Not this menu length list of clear violations of the training.

Then, to be realistic, we'd have to have a single animal (or two at most) found dead or in bad condition by the carestaff. None of this clearly obvious negative outcome stuff. Look, doing the surgical technique is just part of the scientist's job. Presumably she had something else in mind that constituted the real experiment. Having unhealthy or dead animals, post surgery, makes the whole thing a waste of time and valuable resources. The scientist has no motivation to do things that are so obviously going to screw up her data--remember, this is a postdoc. She's not a technician who merely has to look busy*. She has to produce data from these animals. So it is ridiculous to have a scenario where it is clear that health outcome is poor for a large number of the animals used.

More realistic to have a care person find one or two animals in questionable shap. There will be an assertion that was the poor surgical technique, of course, but on investigation it turns out that there is a nonzero failure rate even for the most trained, effective and highly regarded individuals performing the same surgical techniques including the veterinary staff when doing the training or demos or the techniques as a core service. The investigation then descends into trying to determine when poor outcome rises above the background level of performance, institute wide. Possibly across subfields of science. The investigation has to try to figure out if a given level of aseptic/sterile procedure really improves outcome on a group basis...or only sounds good, has no direct benefit and, oh by the way, extends the duration of the surgical technique.

This, to my eye, is where the interesting questions lie. Yes, even for IACUC members. How do you determine the worth of assertions about the "best" way to do a procedure? There should be knowable answers. And taking matters to the utmost excess of sterile surgical proficiency may have no health benefit for the research subjects... while coming at substantial cost to research output. Or, in some cases, there may be actual drawbacks to a seemingly "better" technique, like the duration of surgical anesthesia for a longer process. How do you generate evidence and evaluate it? Can the IACUC demand a lab do two parallel groups with Techniques X and Y and answer the question about outcome?

Dr. Isis ended her post up with an excellent followup question.

The other question that I have that is not specified in the original article is, how culpable is the PI in this? Does she bear any responsibility for not supervising her trainee’s surgeries?

Again, this gets down to real world complexity instead of these trite canned "case studies" in which the blame is so clearly placed. Why was this postdoc feeling so pressed for time? Was the PI demanding a level of output that essentially required her to take shortcuts? Or was it the trainee's own fault, whether because of scattered work ethic, distraction or improper prioritization of her own time budget**? What about other cultural aspects of the lab. Was it made clear that the institutional training provided by the veterinarians or other institutional representatives had the authority inherent in the IACUC protocol, USDA oversight, AAALAC accreditation and AWA structure? Or did the lab communicate "oh, you can safely ignore that stuff" to the trainees?

I return to my usual pollyannaish refrain when it comes to ethical missteps in general cases of scientific misconduct. Scientists are not stupid and did not enter this business because they thought it would be easy to lie, cheat and steal so as to get their name on some obscure journal articles. The obvious no-nos are just that, obvious. So subjecting them to training on the ethical conduct of science that insults their intelligence is going to make them tune out.

If we know that our training is making them tune out and has no real bearing on the ethical quagmires they are likely to encounter in their careers..bad on us. We are derelict in our duties.

I'm not saying every PI needs to jump in and reconstruct the ethics training course at her University. But we need to do more in our more casual, one on one discussions with our trainees. That is where we can have some lasting effect in equipping our trainees for the future when they leave our wonderful and highly ethical laboratories and encounter those weaselly unethical bastiges elsewhere.

I'd like to second the idea that extreme cases rarely make good ethics case studies, except perhaps in a high school classroom. Real life presents far more complicated situations. If all ethics questions were cut and dry, they wouldn't be questions at all.

All I can say is that MY NIH mandated ethics class was a LOT more interesting on animal research day. A LOT more interesting.

Also, the black and white cases are by FAR the most fun!!! They give the devil's advocates a real challenge.
I mean really. These studies should come first? What if the postdoc actually were also a medical resident? I'm sure somebody has research/clinical combined postgraduate training. If her other patients were humans (well, ok, I'd be infinitely more creeped out if her behavior carried over, but we can't ASSUME, that would be the all too tempting fundamental attribution error...), are you SURE this work should come first?

I have seen very dangerous shortcuts, in combination. I'm thinking of sewing the linea in one layer, using only continuous stitches. All it lacked was the mistaken ligation of a major vessel to the organs.

It's late here, and so when I first read Isis's post, the stories I've heard...I didn't think it was a hypothetical. They're rare, but when corners are cut or people get cavalier...they're generally not just a little bit cavalier. They're a lot cavalier.